1. Impact statement Data Integrity Malcolm Holmes 6 May 2015

2. Background Data production Increasingly from computerised systems Still also have manual generation Problems Deliberate falsification / retest till passes / ignore OOS Omission of data through incompetence / naivety Non contemporaneous data Visibility Regulators have found may examples recently Particularly prevalent in countries outside EU / USA and their MRA partners

3. Why Failure to include as part of PQS Criminal activity naivety Cultural aspects Lack of knowledge of requirements

4. Potential Impact Threat to patient safety Current Regulatory inspection target Fines, Import bans, recalls De-listing / licence withdrawal Act now or face regulatory censure Company reputation